Sr Manager Clinical Operations
Reporting to: Director of Clinical Operations
Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically-modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. With a commercial product already, the company has one of the deepest gene therapy pipelines in the industry and is advancing seven clinical-stage programs across multiple therapeutic areas, including inherited neurometabolic disorders, primary immune deficiencies and blood disorders, where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.
Reporting to the Director of Clinical Operations, the Sn Clinical Operations Manager will be accountable for managing the clinical operation activities for 2 to 3 clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.Responsibilities
- Lead, manage and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCP
- Oversees the quality of the clinical operations for the studies he/she is in charge of
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
- Coordinates medical writing and all the activities necessary for delivering of documentation: publishing, QC, etc
- Manages data management and statisticians ensuring data base maintenance, interim and final database locks.
- Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies)
- Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
- Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines
- Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
- Manages CRFs creation, implementation, collaborating closely with data management for the study activities
- Ensures accurate maintenance and archiving of study records
- Management of study budget and timelines
- Management of vendors, including a CRO, to the required standards
- Experience & knowledge of clinical project management
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Understanding of regulatory environment, GCP/ICH
- Experience working in an academic environment is a plus, as well as experience in orphan disease field
Education & skills
- BsC in life sciences
- Msc/PhD in life sciences is a plus
- Excellent organisational and communication skills;
- 'Can-do' attitude and willingness to be flexible
For further information on this role do not hesitate to email [email protected]
All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.